ISO 13485:2016

Medical devices — Quality management systems — Requirements for regulatory purposes

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

The ISO 13485:2016 certification is a proof of Quality Management System compliance to the standard for organizations involved in the Medical Device industry. This approach is not only followed by Medical Device Manufacturers but also supporting organizations such as Subcontractors, Suppliers, European Authorized Representatives, specialized Consulting firms etc…  

Note that ISO 13485:2016 expands the profile of companies and organizations to which the standard can apply:  Organizations involved in one or several stages of a Medical Device Lifecycle or a Supplier or other External Parties providing such organizations with products for example.

Organizations involved in one or more stages of the medical device lifecyle	Suppliers or External Parties who provide products to such Organizations
Design and Development Production Storage Distribution Installation Servicing	Raw materials Components Sub-assemblies Medical devices Sterilization services Calibration services Distribution services Maintenance services

In addition, the ISO 13485 standard requires that the organization identifies its role(s) in connection with the regulatory requirements (e.g. Manufacturer, Representative, Importer and / or Distributor), and determines the applicable regulatory requirements depending on the role(s), then integrates the regulatory requirements in the QMS.

CE Mark

A CE mark is a logo that is placed on medical devices to show they conform to the requirements in the directives. It shows that the device is fit for its intended purpose stated and meets legislation relating to safety. It shows the product can be freely marketed anywhere in the European Union.

The manufacturer must sign a ‘declaration of conformity’ before they can place the CE mark on their product.

The CE marking also means that the product can be freely marketed anywhere in the EU and in India. The mark does not indicate the origin of the product.

Only CE marked medical devices can be placed on the market. The CE mark shows that the device meets the legal requirements for medical devices. To place a CE mark on a medical device, the manufacturer must document the product's quality, safety and performance.

Why do medical devices have to be CE marked?

The CE marking shows that medical devices meet the current EU legislation. The CE marking means that medical devices can be marketed in the EU, provided that the devices meet the national requirements.

However, there is no legal requirement for CE marking of custom-made devices, system and medical treatment packages and devices for clinical investigation.

How to place a CE marking on a product

Before placing a CE marking on a medical device, the device must be covered by the definition of medical devices and be classified correctly in accordance with the classification rules laid down.

Conformity assessment

When the product is in compliance with the requirements for safety and performance, and the technical documentation has been established, the manufacturer must date, sign and keep a declaration of conformity to show that the product complies with the requirements of the executive order.

CE marking

Once the manufacturer has signed the EU declaration of conformity, the CE mark can be placed on the device. The CE mark should be placed visibly, legibly and indelibly on the instructions for use and is a symbol that the product complies with the legal requirements.

The CE mark must also be affixed to the packaging and on the device. On sterile devices, the CE mark should be placed on the package that ensures sterility of the device. The identification number for a notified body has to be placed below the CE mark.

SA-8000

SA8000:2014 is one of the world's first auditable social certification standards for decent workplaces, across all industrial sectors. It is based on conventions of the ILO, UN and national law, and spans industry and corporate codes to create a common language to measure social compliance. It takes a management systems approach by setting out the structures and procedures that companies must adopt in order to ensure that compliance with the standard is continuously reviewed. Facilities seeking to comply with SA8000 have to adopt policies and procedures that protect the basic human rights of workers.

V- Cert conducts self reference assessment of your organisation’s compliance to SA8000 standard. We also issue a detailed report about the status of the implementation in all your process, including your supply chain.

The nine elements in the SA8000 Standard are:

• Child Labor
• Forced & Compulsory Labor
• Health & Safety
• Freedom of Association & Right to Collective Bargaining
• Discrimination
• Disciplinary Practices
• Working Hours
• Remuneration
• Management Systems

BSCI (Business Social Compliance Initiative)
Reinforce the confidence of the customer

The Social Compliance Initiative (BSCI) is a leading business-driven initiative for companies committed to improving working conditions in factories and farms worldwide. The BSCI Code of Conduct is based on the most important international labour standards protecting the workers' rights such as the International LabourOrganization (ILO) Conventions and other important Declarations of the United Nations, the OECD guidelines for multinational enterprises and the UN Global Compact. By undergoing a BSCI audit a facility expresses its strong commitment towards fair working conditions, including its supply chain. BSCI audit is a strong foundation for SA 8000 certification in future and it saves a lot of time and money in achieving the same.V- Cert conduct self reference assessment of your organisation’s compliance to BSCI Code of Conduct and issue a detailed report about the status of the implementation in all your process, including your supply chain.

Goal of BSCI code of contuct

• Freedom of association and the right to collective bargaining are respected.
• No discrimination is practised.
• Child Labour is prohibited
• Legal minimum and/or industry standards wages are paid.
• Working hours are compliant with national laws and do not exceed 48 hours regular + 12 hours overtime.
• There is no forced labour and disciplinary measures.
• The workplace is safe and healthy.
• The environment is respected.
• The is a policy for social accountability
• There is anti-bribery and anti-corruption policy.

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SEDEX (Supplier Ethical Data Exchange)
Empowering sustainable and ethical supply chains

SEDEX, the Supplier Ethical Data Exchange, is a not for profit membership organisation dedicated to driving improvements in responsible and ethical business practices in global supply chains. Sedex offers a simple and effective way of managing ethical and responsible practices in your supply chain.

The core product is a secure, online database which allows members to store, share and report on information on four key areas - Labour Standards, Health & Safety, The Environment and Business Ethics.Sedex provides an efficient and cost effective way of sharing ethical information with multiple customers, helping cut down on unnecessary paperwork and saving you time and money.

The Sedex system is secure and confidential and suppliers have complete control over who can view their data.

By allowing suppliers to share the same data with many customers, Sedex helps reduce the need for multiple audits, allowing both parties to concentrate on making real improvements.

V- Cert conduct self reference assessment of your organisation’s compliance to SEDEX (ETI Base Code) and issue a detailed report about the status of the implementation in all your process, including your supply chain.

ISO 9001:2015
Gaining competitive advantage through quality

ISO 9001:2015 is an international standard on quality management system based on eight quality management system principles to help improve organizational performance:

• Customer focus; leadership
• Involvement of people.
• Process approach.
• System approach to management.
• Continual improvement.
• Factual approach to decision making.
• Mutually beneficial supplier relationship.

With greater emphasis on customer satisfaction, process management and measurement and continual improvement with greater top management involvement, certification to ISO 9001 helps you demonstrate to customers that you have a commitment to quality.

ISO 9001 is known as a “generic quality management system standard” which means that the standard can be applied:

• To any large or small organization, whatever its size, its product or service
• In any sector of activity, whether it is a business enterprise, a public administration, or a government department.
• In any industry, for example, whether it is an engineering company, a manufacturer, a logistic company, a welfare organization, an international law firm, a bank, a chemical processing plant, a hospital, a hotel, a university or a restaurant.

C-TPAT Audits
Building cooperative relationships to improve the U.S. border safety

The Customs-Trade Partnership Against Terrorism (C-TPAT) is a voluntary supply chain security program led by U.S. Customs and Border Protection (CBP) and focused on improving the security of the supply chains of companies which import cargo from foreign countries like India, China, Bangladesh etc, with respect to terrorism. The U.S. Customs and Border Patrol (CBP) identifies trusted import traders with good supply chain security protocols, thereby reducing its need to screen their imported cargo.

V-Cert conducts independent assessment of compliance to C-TPAT requirements based on a powerful and effective Supply Chain Security Audit Tool which is based on C-TPAT Requirements.

Our experienced and trained auditors assess your organization’s security processes, identify corrective actions and establish improvement plans to address areas of concern. We can also conduct periodical audit of your company.

The C-TPAT audit process typically consists of four steps:

• Our audit team defines an audit program based on C-TPAT requirements and our audit checklist.
• Our auditors conduct an on-site audit at your locations.
• On completion of the audit, we prepare a complete and transparent audit report, along with recommendations for improvement. This report is reviewed by our technical reviewers before it is sent to all relevant parties named in our contract.
• We continue to monitor your C-TPAT compliance as per the agreement entered between us.